Kornimate/medical-research-clean huggingface dataset:
anosognosia evaluation after cranocerebral trauma moderate to severe

Conditions: Traumatic Brain Injury

Summary: this study is conducted over 18 months. the main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia. secondary objectives are : * identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia * explore the links between the anosognosia manifestations and the psychological manifestations

this experimental protocol is proposed to 40 patients who have a moderate or severe traumatic brain injury. all of this protocol is 2 hours, tasks are administered in the order named. to measure anosognosia, this protocol is to administer 4 questionnaires used in clinical routine who have proposed to patients and their therapist and relative who know them well. the chosen measure is the difference between the results of the patient and that of the therapist or relative. others evaluations are administrated to question the beliefs capacity during 2 certainty of judgment tasks replicated or adapted articles from the literature (tasks of guessing and task of judgments facts). the patients are also evaluated through several executive tasks (who come from battery of tests called 'groupe de reflexion sur l'évaluation des fonctions exécutives') and global cognitive efficiency tasks from the wechsler adult intelligence scale (involving non-verbal reasoning, psychomotor speed and general knowledge). these different tests measure the capacity of inhibition, mental flexibility, planning and information generation. at last, mood and coping strategy questionnaires are proposed to patients for complete this protocol. this protocol are also administered to 40 volunteers who have not had traumatic brain injury to monitor standards in general population (because all these tasks are not systematically standardized).

Eligibility criteria:
inclusion criteria: * patients with a moderate or severe traumatic brain injury occurred at least 3 months ago (glasgow ≤ 12 or duration of post-traumatic amnesia \> 1 week) * patients ≥ 18 years old and who have signed a letter of information exclusion criteria : * motor, sensitive and phasic disorders who are not allowing the test passation * neurological or psychiatric antecedents * patients who refused to participate in the study * non affiliation to a social security scheme * patients under guardianship or trusteeship

Keywords: anosognosia
the efficacy of si-ni-tang (a chinese herbal formula) for severe sepsis

Conditions: Severe Sepsis

Summary: the purpose of this study is to evaluate the efficacy of si-ni-tang (a chinese herbal formula documented in shang han lun) in treating severe sepsis.


Eligibility criteria:
inclusion criteria: * severe sepsis (according to american college of chest physicians/ society of critical care medicine (accp/sccm) criteria) * informed consent provided by patients or legally authorized representative * yin syndrome in syndrome differentiation (according to principles of traditional chinese medicine (tcm) syndrome differentiation) exclusion criteria: * pregnant or nursing female * subject receiving immunosuppressive or immunoenhancement therapy in the past 3 months * patients with known or suspicious autoimmune diseases * patients not expected to survive 28 days due to end-stage disease or other uncorrectable medical condition * fasting subjects * known or suspicious allergy to any ingredient of si-ni-tang * patients not expected to survive 5 days for various reasons

Keywords: severe sepsis sini decoction immune function mortality
phase i study of liposome-mediated gene transfer in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: objectives: evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis transmembrane conductance regulator gene to nasal epithelium in patients with cystic fibrosis.

protocol outline: cystic fibrosis transmembrane conductance regulator (cftr) gene complexed with lipid is administered intranasally to the right inferior turbinate. lipid without cftr is administered to the left nostril as a control. cohorts of 3 patients are given successively lower doses of cftr, each dose complexed with 500 micrograms of lipid. patients are followed at days 2-12, 15, and 21, then every 3-4 days for 3 weeks, every 2-3 weeks for 10 weeks, and every 3 months thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- cystic fibrosis (cf), i.e.: sweat chloride greater than 60 meq/l clinical manifestations of cf homozygous delta f508 mutation preferred compound heterozygotes for f508 mutation with pancreatic insufficiency eligible fev1 greater than 40% of predicted po2 at least 60 mm hg on room air no acute or recurrent sinusitis no obstructive nasal polyposis no pneumothorax or hemoptysis, e.g., more than 250 ml blood within 24-hour period, within past year no unstable lung disease with worsening pulmonary symptoms, arterial blood gas, or pulmonary function tests within 2 weeks prior to entry no pulmonary exacerbation within 4 weeks prior to entry --prior/concurrent therapy-- at least 2 months since participation in any other clinical study at least 2 months since dnase at least 4 months since corticosteroids --patient characteristics-- cardiac: no severe cardiac disease other: no other severe organ system disease, e.g., juvenile-type diabetes mellitus no pregnant women

Keywords: cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease
effect of early pain management at triage on opioid consumption

Conditions: Acute Pain

Summary: introduction: pain remains one of the most common reasons of emergency department admission. opioids are overprescribed in emergency departments to treat severe pain. objective: assessing the impact of ealy pain pain management on the use of intravenous morphine and on patient satisfaction.


Eligibility criteria:
inclusion criteria: * over 18 years of age * a visual analog scale (vas) equal to or higher than 30/100 , * having given consent to participation * no contraindications to products used in the course of the study. exclusion criteria: * having a vital distress that does not allow an adequate assessment of the intensity of the pain * an inability to assess pain intensity according to the vas, * swallowing disorders or inability , or a contraindication or an allergy to the treatments used.

Keywords: acute pain emergency department opioid consumption
effect of ramosetron in prevention of intrathecal morphine induced nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: we would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .

the patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. treatment allocations were contained in sealed envelopes that were opened after patient enrollment. patients received either 8 mg of intravenous (iv) ondansetron or 0.3 mg of iv ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. all of the unilateral tkas were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis. patients were monitored for incidence of post operative nausea vomiting(ponv) every 6 hours until 24 hours, and 24-48 hours postoperatively. common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded. the sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.

Eligibility criteria:
inclusion criteria: * patients aged 50-80 years with a diagnosis of primary oa undergoing unilateral tka * american society of anesthesiologist (asa) physical status i-iii * giving written informed consent exclusion criteria: * body mass index (bmi) \> 35 kg/m2 * unable to undergo spinal anesthesia * history of allergic to study drugs * impaired renal and/or hepatic function * use of systemic steroids and anti-emetics within 24 hours of operation

Keywords: total knee arthroplasty intrathecal morphine ramosetron ondansetron postoperative nausea and vomiting
validity of web-based osdi-6 questionnaire in a chinese adult population

Conditions: Dry Eye

Summary: this study aimed to evaluate the validity of the chinese translation version of osdi-6 (c-osdi-6) in a theoretical set-up of two questionnaire groups for dry eye

screening for dry eye symptoms and quantifying dry eye symptoms aids in assessment, diagnosis, and treatment. patient-reported outcome (pro) instruments such as the ocular surface disease index (osdi-12) are utilized for assessing patients' subjective experiences and functional abilities. the osdi-12 comprises of 12-item and is often used in conjunction with other tests in clinical settings to assess individuals with de. created in 1997, the original osdi consisted of 12 items and was designed to evaluate subjective dry eye symptoms and the consequences of ded on vision-related activities of daily life over the preceding week. the 12 items are grouped into three subscales: ocular symptoms (three items), vision-related functions (six items), and environmental triggers (three items). while the original version of the osdi-12 questionnaire was created in english and was later translated and validated into other languages, it should be used carefully since the cutoff values vary among various languages (27.2 points for the chinese version and 36.3 points for the japanese version) . recent research using rasch analysis found that separating answer items into four categories by merging "half of the time" and "most of the time" might lead to higher thresholds and better intervals in each category. the osdi-12 total score is calculated using the formula: \[(sum of scores for all questions answered) × 100\]/ \[(total number of questions answered) × 4\]. ocular surface disease index-6 (osdi-6) is a derivative and shortened version of the original osdi-12 and can potentially improve efficiency in a busy clinical setting.

Eligibility criteria:
inclusion criteria: * diagnosed dry eye * able and willing to comply with the schedule * able to read and understand the c-osdi-12 questionnaire independently exclusion criteria: * the researchers judged to be not suitable

Keywords: qestionnaire
registry: tpla for luts

Conditions: Lower Urinary Tract Symptoms; Benign Prostate Hyperplasia; Benign Prostatic Hypertrophy With Outflow Obstruction

Summary: rationale: the treatment of lower urinary tract symptoms (luts) due to benign prostatic enlargement in men with transperineal laser ablation (tpla) may offer advantages in functional outcomes and safety over current standard therapies. as the technique is relatively new, indications and outcomes for this treatment are subject of investigation. however, the technique is already applied outside clinical studies. clinical information from these treatments can be useful for future research. the aim of this study is to collect data on patients treated with transperineal laser ablation of the prostate outside clinical trials and to provide data on safety and functional outcomes in these patients in order to improve treatment. objective: to assess long-term efficacy of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations. study design: this is an international prospective observational study in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms. study population: male patients treated with transperineal laser ablation for lower urinary tract symptoms due to benign prostatic enlargement. main study parameters/endpoints: the primary endpoint of this study is long-term efficacy of transperineal laser ablation for lower urinary tract symptoms measured by the time until surgical retreatment.


Eligibility criteria:
inclusion criteria: * male * presenting with lower urinary tract symptoms * indication for transperineal laser ablation * signed informed consent form exclusion criteria: * age \< 18 years * previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)

Keywords: transperineal laser ablation luts
post-marketing surveillance of long-term observation of gliadel wafer-investigation of vital prognosis in patients with high grade glioma

Conditions: Malignant Glioma

Summary: the objective of this study is to determine the survival status of patients enrolled in study gli01s (all-case observational study).


Eligibility criteria:
inclusion criteria: * malignant glioma, patients enrolled in study gli01s. exclusion criteria: * corresponding to contraindication of gliadel. * not applicable to indications of gliadel.

Keywords: malignant glioma glioblastoma multiforme
the application of a wireless sensor technology for vital statistics in children and adults

Conditions: Fever; COPD; Obesity; Congenital Heart Disease; Respiratory Distress

Summary: the primary outcome for this project will be the development of a small, non-invasive wireless sensor that is linked to a conventional computer that can be used in health care for monitoring of acute and chronic health problems. the advantages of developing this technology are threefold. first, monitoring can be conducted for a fraction of the cost of a bedside nurse. second, monitoring can be done in real time and stored so that we can diagnose and manage critical events in a more timely manner. lastly, many patients can be monitored simultaneously. the wireless sensors will be fitted to healthy volunteers of various ages. the data gathered from the sensor with respect to their vital signs will be compared to that of conventional tools such as nursing assessments and pulse oximetry.


Eligibility criteria:
inclusion criteria: * adults with controlled and non-controlled hypertension (hypertension defined as \> 130/90 on two separate occasions and history of hypertension) * adults with known chronic obstructive pulmonary disease in respiratory distress with oxygen saturations \< 90% * febrile adults (temp at triage \> 38 c) with no significant co-morbidities * elderly (\>70 years) patients with no significant co-morbidities * obese adults (bmi \> 30) * febrile (temp at triage \> 38 c) and non-febrile children (age \< 18 yrs) * obese children (bmi \> 30) * neonates (age \< 6 weeks) * children with corrected cyanotic congenital heart disease * children in respiratory distress that present with oxygen saturations \< 90% exclusion criteria: -subjects with unstable vital signs will be excluded.

Keywords: wireless pressure sensor elderly
infraclavicular or supraclavicular brachial plexus blocks for elbow surgery

Conditions: Cubital Tunnel Syndrome; Biceps Tendon Rupture

Summary: this study compares the infraclavicular approach to supraclavicular approach of brachial plexus block for elbow surgery.

traditionally, infraclavicular as well as supraclavicular approaches to brachial plexus have been recommended for elbow surgery. supraclavicular approach is considered to have a more rapid onset. however, investigators have noticed that the supraclavicular approach needs more supplementation if it is used for elbow surgery. therefore more and more anesthesiologists now choose the infraclavicular approach for elbow surgery (though both approaches are recommended in the text books). none of the published studies have addressed if one approach is indeed superior to the other specifically for elbow surgery. therefore the investigators propose to undertake a study that will evaluate the two approaches to the brachial plexus specifically for elbow surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled for ambulatory elbow surgery under block * asa 1-3 exclusion criteria: * narcotic dependent * severe systemic illness * refusal of block * localized infection

Keywords: elbow
sitosterolemia metabolism

Conditions: Sitosterolemia

Summary: ezetimibe has become the treatment choice for patients with sitosterolemia. ezetimibe is an inhibitor of cholesterol absorption from the gastrointestinal tract. the purpose of this study is to determine if ezetimibe improves whole body plant sterol and cholesterol homeostasis.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of homozygous sitosterolemia as established by genotyping and clinical parameters exclusion criteria: * pregnant * intellectual disability * major infectious diseases * immunodeficiency * cancer * renal failure * diabetes

Keywords: sitosterolemia ezetimibe plant sterol cholesterol
awareness of climate change impacts among university students

Conditions: Climate Change

Summary: this study evaluates college students' awareness of climate change and its effects on the environment through a questionnaire.


Eligibility criteria:
inclusion criteria: * all the university students are eligible to participate in the study exclusion criteria: -

Keywords: climate change, college students, awareness
the prediction biomarkers of survival outcome for severe immune-related hepatitis

Conditions: Lung Cancer

Summary: immune checkpoint inhibitors have revolutionized lung cancer (lc) treatment, demonstrating a significant improvement in overall survival. however high-grade immune-related adverse events (iraes) may result in harmful and serious clinical outcomes, even death. immune-related hepatitis (irh) is a potentially serious complication of checkpoint blockade, with an incidence of 5%-10% for icis monotherapy, including 1%-2% with grade 3 or higher. therefore, it is particularly important to explore new and better prognostic and predictive biomarkers for irh.


Eligibility criteria:
inclusion criteria: * the lung cancers were diagnosed by pathological evaluation. * the pd-1/pd-l1 inhibitors were administered in all patients. * grade 3-5 immune-related hepatitis had occurred. * the pre-treatment tissues or peripheral blood were available. exclusion criteria: * the pathological type was not lung cancers. * grade 1-2 immune-related hepatitis would be excluded. * the any-grade hepatitis were induced by chemotherapy or virus.
safety and performance of endomatic sepiola left atrial appendage (laa) closure device

Conditions: Atrial Fibrillation

Summary: the study is designed to evaluate the safety and performance of the endomatic sepiola left atrial appendage (laa) closure device in patients with non-valvular atrial fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy. potential patients who are candidates for laa closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure. all enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge. additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.


Eligibility criteria:
inclusion criteria: * calculated cha2ds2-vasc score of 2 or greater. * the subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants. * documented non-valvular atrial fibrillation * subject suitable for vascular/cardiac intervention procedure * suitable laa anatomical measurements for study device exclusion criteria: * subject who requires anticoagulation for a condition other than af. * nyha classification iv. * complex congenital heart disease. * presence of circumflex coronary artery stent. * the subject has a prosthetic valve in any position. * atrial septal defect closure or has an asd/pfo device. * presence of intracardiac thrombus. * any cardiac surgery in the past * lvef \< 35%. * intracardiac thrombus * moderate or severe mitral valve stenosis
occupational hand eczema - testing of a prevention-concept

Conditions: Occupational Contact Dermatitis

Summary: randomised controlled trial examining the effect of decreased waiting time for the first doctors' appointment, patient education, glove counselling and counselling at departments of social or occupational medicine on severity of hand eczema, quality of life, use of corticosteroids, and jobsituation 3-12 months after intervention in patients with suspected occupational contact dermatitis of the hands.

patients with suspected occupational hand eczema are recruited to the study on basis of their referral from general practitioner to dermatologist. patients are randomised to either control or intervention group. the control group is treated and followed-up by the dermatologist they have been referred to, while the intervention group is treated and followed-up at gentofte hospital skin department with a maximum waiting time of 3 weeks. at the skin department at gentofte hospital, the patients in the intervention group receive patient education in prevention and treatment of hand eczema, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. patients in both the control and intervention group are asked to fill out a questionnaire at 3, 6, 9 and 12 months after inclusion in the study. the questionnaire contains questions about quality of life, severity of hand exzema, jobsituation, use of healthcare service and use of medicine. furthermore, prescriptions of medicine are registered in both control and intervention group at 3, 6, 9 and 12 months.

Eligibility criteria:
inclusion criteria: * referred from a general practitioner to a dermatologist * hand eczema within the last 3 months * suspicion that the hand eczema is work-related (either patient and/or doctors suspicion) exclusion criteria: * does not read and write danish * severe psychiatric illness * pregnancy